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The Business Continuity profession has seen rapid and explosive growth in the days since 9/11. On that terrible day, the significant difference between those businesses housed in the World Trade Centers that would reopen and those t

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

hat would close was the degree of business process resilience that business possessed.

The years since 9/11 have seen businesses large and small implementing not only data redundancy, but continuity planning for all critical busine

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

s processes. To be sure, healthcare has also implemented data redundancy and business process continuity planning for business and administrative activities, but what about the true business of healthcare?

Business continuity plann

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ng is designed to preserve those critical business processes that must be preserved to maintain operations and profitability. For an investment company, those processes include data storage, client accounting and real time financial

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

processing to mention just a few. Healthcare business contingency planning is directed at supporting such processes as data storage, client accounting and real time financial processing; but does this support the mission of healthc

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

re?

An investment company is in the business of managing money and markets; their business continuity planning supports that mission. Healthcare is in the business of delivering medical care. Currently healthcare business continuit

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

is split between two professionals, the business continuity professional and the medical contingency planner/safety officer. The business continuity professional is charged with ensuring that the financial and administrative proces

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ses of the healthcare business are maintained. The Medical contingency planner/safety officer is charged with ensuring that the delivery of healthcare continues uninterrupted. But the does this split approach support the mission of

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ealthcare?

Healthcare business continuity planning must preserve those critical business processes required to maintain operations and profitability. This by necessity includes both critical medical services and critical financial

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

nd administrative processes. However, most healthcare institutions in the United States are private sector businesses. These businesses do not meet their operational budgets with emergency medical services or even general hospital a

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

missions. This was borne out in the late 1970’s and early 1980’s when the losses in emergency medical services caused hospitals to either close or restrict services in the emergency room. In an effort to stop this trend, Congress pa

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ssed the 1986 Emergency Medical Treatment and Active Labor Act (EMTALA). In 2007, healthcare institutions subsidize the unfunded EMTALA mandate with outpatient services. These are the very services that most medical contingency plan

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ers/safety officers close when disaster strikes.

Like business contingency planning, healthcare disaster planning begins with a vulnerability analysis; however, unlike the business vulnerability analysis which focuses on identifyin

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

critical business processes, the healthcare vulnerability analysis focuses on quantitating external threats. Healthcare disaster planning is based on an “All Hazards” approach. Despite the apparent emphasis on external threats, an

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

“All Hazards” approach is meant to be “Process Hazards” approach. Here in is the challenge for the medical contingency planner/safety officer and the new market opportunity for the business continuity professional.

Healthcare desp

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

rately needs a planning professional who can combine the healthcare vulnerability analysis with the business process vulnerability analysis. The average daily revenue loss for a hospital that closes outpatient services following a d

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

saster is a quarter of a million dollars. In addition, financial losses occur as a result of process failures in registration, charge entry and billing. The delivery of healthcare services frequently suffers as a result of process f

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ailures during disaster that cause a backlog of patients and a loss of efficiency. Healthcare disaster planning based on standard healthcare vulnerability analysis combined with process vulnerability analysis would not only address

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

he business process continuity, but would highlight medical process vulnerabilities allowing limited medical resources to be concentrated on medical process continuity. Finally an attention to business continuity focusing on the pri

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ary mission of the healthcare institution to deliver healthcare and maintain profitability would support the business processes and the medical processes while quickly returning to normal operations to restore all streams of revenue

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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